MAUDE Adverse Event Report: LIKO (HILL-ROM INC.) GOLVO; LIFT, PATIENT, AC-POWERED

Model Number 8008

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Injury (2348)

Event Date 05/08/2017

Event Type  malfunction  

Event Description

Nurse started to raise the patient with a liko golvo 8008 lift, and as the patient was suspended above right side of bed the equipment stopped lifting and began to tilt forward, raising the back of the lift.The nurse gently guided the patient a bit diagonally down into their bed.Apparently this motion caused an employee injury.The original call was placed to biomed as the machine malfunctioned and our biomeds completed a full preventative maintenance on the unit and everything was working as designed.The battery seems a bit weak, so our tech purchased one and replaced it.The unit was taken right back to service.Due to the fact that the employee injury was brought up at a later date we had a liko rep come out and check out the unit.This was the sales person, who also teaches staff how to use the equipment.After 3 days of being on site this was deemed a user error as the rep found the lifting strap wrinkled which means that someone had continuously pulled on the strap at an angle and the strap had bunched up inside the opening on several occasion, this could make the unit stop lifting.The rep did some retraining on usage and the unit has been back in service since without failure.Manufacturer response for patient lift, golvo 8008 (per site reporter): they came out, tested operation, deemed user error, and did some retraining.

• Brand Name: GOLVO
• Type of Device: LIFT, PATIENT, AC-POWERED
• Manufacturer (Section D): LIKO (HILL-ROM INC.); 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 6893674
• MDR Text Key: 87344047
• Report Number: 6893674
• Device Sequence Number: 1
• Product Code: FNG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 8008
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/20/2017
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other